AzNETT NEWSLETTER. Mission: The mission of the. Vision: NETT will engage clinicians and

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1 AzNETT NEWSLETTER Mission: The mission of the Neurologic Emergencies Treatment Trials (NETT) Network is to improve outcomes of patients with acute neurologic problems through innovative research focused on the emergent phase of patient care. Vision: NETT will engage clinicians and providers at the front lines of emergency care to conduct large, simple multicenter clinical trials to answer research questions of clinical importance. The NETT structure will be utilized to achieve economies of scale enabling cost effective, high quality research. Page 1 August 2009

2 Glendale Fire, a spoke of University of Arizona hub, has enrolled 2 subjects in RAMPART!! Glendale Fire worked diligently with our Phoenix research team to have this study up and running. Glendale Fire has the distinction of enrolling the first pediatric subject. Strong Work!! Sheryl Wurl, PhD is appointed as the new Human Subjects Protection Program Director at the University of Arizona. Dr. Wurl is coming to us from the University of Tennessee Medical Center where she held the position Director of Clinical Pastoral Education. She will be starting with University of Arizona mid-september. Do what you can, with what you have, where you are. ~Theodore Roosevelt Page 2 August 2009

3 What conditions need to be present to run a study under Exception From Informed Consent (EFIC)? The subject is in a life threatening condition Existing treatments are unproven or unsatisfactory The collection of scientifically valid evidence is necessary to determine the safety and effectiveness of particular interventions. Obtaining consent before intervention is not possible or practicable. Participation in the research holds out the prospect of direct benefit to the subjects. The research could not practicably be carried out without the waiver. Consent for further inclusion in the study must be obtained as soon as possible after the patient arrives at an Emergency Department. RAMPART is the first prehospital EFIC trial deployed in Arizona. ProTect will also be an EFIC trial. Page 3 August 2009

4 AzNETT Hub: University of Arizona ALIAS Tucson: UMC, UPHK RAMPART Phoenix: JCL NM and DV, Banner Thunderbird, Arrowhead Community, Maryvale Hospital PROTECT Tucson: UMC Phoenix: Good Sam CLINICAL TRIALS ALIAS - Albumin in Acute Stroke Trial PI: Myron Ginsberg, MD - University of Miami Primary Objective: To determine whether albumin therapy increases the proportion of acute ischemic stroke patients with favorable outcome compared to placebo therapy at 3 months from randomization. Status: Two patients enrolled and twenty-eight screened. Nationwide, there are 90 patients enrolled. Page 4 August 2009

5 RAMPART - Rapid Anticonvulsant Medication Prior to Arrival Trial PI: Robert Silbergleit, MD - University of Michigan Primary Objective: To determine if the efficacy of intramuscular (IM) midazolam is not inferior to intravenous (IV) lorazepam by a prespecified clinically unimportant absolute difference in the prehospital treatment of status epilepticus. Status: 2 patients enrolled, 5 screened. Nationally 48 patients enrolled. ProTECT - Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment PI: David Wright, MD - Emory University Primary Objective: To determine the effectiveness of intravenous progesterone initiated within 4 hours of injury and administered for 72 hours as compared to placebo at improving functional outcome in patients with moderate to severe traumatic brain injury. Status: Notice of Award received! Surveys are out to hub sites to collect information on treating traumatic brain injury. Preliminary Protocol was sent to sites. Our hub will be putting together a community consultation/public disclosure plan. We expect enrollment to start in spring Page 5 August 2009

6 Please direct any questions you have regarding AzNETT to: Principal Investigator, Tucson: Kurt Denninghoff, MD phone Research Nurse Coordinator, Tucson: Ginny Rizzo, RN, CCRC phone Research Nurse Coordinator, Phoenix: Bruce Barnhart, RN, CEP phone EMS Coordinator, Phoenix: Willie Haro, CEP phone AEMRC Administrative Assistant: Ronnie Benke phone We look forward to working with you! Page 6 August 2009